How does SMC decide which medicines to accept?

Medicines can prolong life, improve the quality of life, or both.

As the health service has limited money to spend, difficult choices have to be made about what treatments can be made routinely available; the decision to make a treatment available for one group of patients may mean that treatments cannot be provided for another patient population.

The SMC Committee takes a range of factors into consideration when deciding whether to accept a new medicine under review. The committee considers the clinical and health economic evidence provided by the submitting company as well as evidence submitted by patient groups to decide whether the medicine provides value for money.

Find out more about how our pharmacists assess a medicine

Watch Nick Murray, one of our Pharmaceutical Analysts, explain how we assess a new medicine

What do we mean by value for money?

SMC evaluates every medicine submitted in terms of whether the benefits for patients may be considered an acceptable use of NHS resources.

When we talk about value for money or cost effectiveness, this does not just mean how much a medicine costs to buy, but the wider costs and benefits associated with it being regularly used to treat those with a particular condition, for example:

  • what benefits the medicine offers compared to other currently available treatments
  • the quality of life and amount of extra life that may be gained by patients using the new medicine
  • how the medicine is administered (for example, does it require a visit to a clinic or can it be taken by the patient at home?)
  • will it save money downstream, for example if the patient will have fewer hospital admissions due to complications from their condition, and
  • if there are any additional GP/other healthcare professional visits required.

Find out more about how we assess value for money

Watch our Lead Health Economist Ailsa Brown talk about cost effectiveness and health technology assessment or download our guide to Quality Adjusted Life Years (QALYs).

Medicines for end of life and very rare conditions

We use the following definitions:

  • End of life medicine: a medicine used to treat a condition at a stage that usually leads to death within three years with currently available treatments.
  • Orphan medicines used for very rare conditions: a medicine with European Medicines Agency (EMA) designated orphan status (conditions affecting fewer than 2,500 people in a population of 5 million) or a medicine to treat an equivalent size of population irrespective of whether it has orphan status.
  • Ultra-orphan medicine: medicines for extremely rare conditions may be known as ultra-orphan medicines. SMC uses this term for medicines used to treat conditions with a prevalence of 1 in 50,000 or less (or a maximum of 100 people in Scotland).

For medicines used at the end of life and for very rare conditions, if the preliminary advice from our New Drugs Committee (NDC) is to not recommend the medicine, the pharmaceutical company may ask for the medicine to be considered at a Patient and Clinician Engagement (PACE) meeting. This additional step allows SMC to hear more evidence from patient groups and clinicians on the added value of a medicine which may not always be captured in the company’s submission. At this stage the company can also submit or improve a Patient Access Scheme (PAS), which can help to improve the value for money of the medicine. The output from a PACE meeting is a major factor in SMC decision making.

 

Find out about Patient Access Schemes

 

Find out more about PACE

Ultra-orphan medicines

For medicines categorised as ultra-orphan, we use a framework of explicit decision-making criteria that emphasises:

  • the nature of the condition
  • the impact of the new medicine, and
  • its value for money.

This allows the committee to consider the wider impact a medicine may have for patients and their carers beyond direct health benefits (such as being able to return to work or patient’s out of pocket expenses), and the medicine’s impact on specialist services and costs to the NHS and social care services.

A company can request a PACE meeting for an ultra-orphan medicine.

Who decides?

Decisions are made by the SMC Committee at their monthly meeting by a majority vote.

Find out who sits on the committee

Find out more about how our committee members consider evidence about a new medicine

Our Co-Vice Chair, Gail Caldwell, explains how committee members consider evidence about a new medicine.

SMC decisions

SMC can make one of three decisions on a medicine:

  • accepted
  • accepted with a restriction(s) (for example, the medicine can only be recommended in a particular group of patients with the condition. This typically occurs because the company has requested this explicitly in their submission), and
  • not recommended.

The committee now also has the opportunity to accept some medicines on an interim basis subject to ongoing evaluation and reassessment.

Find out more about interim acceptance


Common reasons for not being able to recommending a medicine are:

  • the medicine is no better than cheaper products already in use, 
  • the additional benefits of the medicine do not provide good value for money to the health service and / or
  • the case for the medicine is uncertain or not robust enough (for example, there were uncertainties or weaknesses associated with the evidence used to estimate the value for money of the medicine)

Once a decision is made, it is shared in confidence with NHS boards and the pharmaceutical company four weeks before it is published to ensure that Area Drug and Therapeutics Committees (ADTCs) can take steps to prepare for the introduction of the new medicine in health boards.

SMC is a great demonstration of how the HTA process can really work well. I would have said the same thing even if the decision had been different - we felt our views were taken seriously.

Russell Wheeler, Trustee, LHON Society (Patient group partner)

Availability of medicines in the NHS following SMC decisions

When SMC accepts a new medicine, NHS boards are expected to make it, or an equivalent SMC-accepted medicine, available. NHS boards publish the medicines included and excluded from their formularies together with the reasons for such decisions. 

Where a medicine is not recommended by SMC, the company can make an improved resubmission at any time.

All NHS boards have procedures in place to consider requests for the use of a medicine in an individual patient when a doctor feels this would be appropriate.

Medicines awaiting SMC appraisal

We actively encourage submissions from pharmaceutical companies to ensure medicines can be made available as soon as possible. If a company decides not to make a submission to SMC, we advise health boards that the medicine cannot be recommended for routine use.